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MUMBAI: Price of patented drugs will be halved as soon as they lose patent protection or are on the verge of going off patent in India, providing much-needed relief to patients, reports Rupali Mukherjee.
The price of the drug losing patent will be slashed by 50%, and after a year, the MRP will change in tandem with the change in the Wholesale Price Index as stipulated for scheduled drugs, a government notification accessed by TOI said. The policy change will reflect in the Drug (Prices Control) Amendment 2023.
“Over the last few years, the government has been following this principle. Now, it has been formalised,” an industry expert said. Typically, once the drug loses its monopoly status globally, prices crash as low as 90% with the entry of generic versions.
The government’s decision provides clarity on prices that multinational pharma majors can charge on blockbuster drugs that are going off patent. This has been a thorny issue for years now, with MNCs and the government being unable to resolve it.
Over the last few years, prices of popular anti-diabetics including Vildagliptin and Sitagliptin, and cardiac drugs including Valsartan have crashed after losing monopoly. Subsequently, the National Pharmaceutical Pricing Authority also fixed ceiling prices of the two drugs to improve their affordability and accessibility.
“Once the patent expires, high-quality generics can enter the market to help lower the overall cost of healthcare and improve access to medicines. Price per tablet for patients comes down, and the market shifts to a more affordable treatment, which can then be prescribed to a larger set of patients. Usually for innovator drugs, it is a high-volume and high-growth market so there is room for good players,” an industry expert said.
Overall, for patented medicines, the policy is yet to be firmed up due to a divergence in views. In the past, the government has constituted several committees and discussed multiple methods including negotiations and reference pricing, for evolving a price mechanism. Experts have expressed the view that the price of patented medicines, even after negotiation, will remain unaffordable for a majority of the population.
The price of the drug losing patent will be slashed by 50%, and after a year, the MRP will change in tandem with the change in the Wholesale Price Index as stipulated for scheduled drugs, a government notification accessed by TOI said. The policy change will reflect in the Drug (Prices Control) Amendment 2023.
“Over the last few years, the government has been following this principle. Now, it has been formalised,” an industry expert said. Typically, once the drug loses its monopoly status globally, prices crash as low as 90% with the entry of generic versions.
The government’s decision provides clarity on prices that multinational pharma majors can charge on blockbuster drugs that are going off patent. This has been a thorny issue for years now, with MNCs and the government being unable to resolve it.
Over the last few years, prices of popular anti-diabetics including Vildagliptin and Sitagliptin, and cardiac drugs including Valsartan have crashed after losing monopoly. Subsequently, the National Pharmaceutical Pricing Authority also fixed ceiling prices of the two drugs to improve their affordability and accessibility.
“Once the patent expires, high-quality generics can enter the market to help lower the overall cost of healthcare and improve access to medicines. Price per tablet for patients comes down, and the market shifts to a more affordable treatment, which can then be prescribed to a larger set of patients. Usually for innovator drugs, it is a high-volume and high-growth market so there is room for good players,” an industry expert said.
Overall, for patented medicines, the policy is yet to be firmed up due to a divergence in views. In the past, the government has constituted several committees and discussed multiple methods including negotiations and reference pricing, for evolving a price mechanism. Experts have expressed the view that the price of patented medicines, even after negotiation, will remain unaffordable for a majority of the population.
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